Tiotropium and Salmeterol PK Study in COPD Patients

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to characterize the pharmacokinetics (i.e. systemic exposure to tiotropium and salmeterol) of tiotropium qd + salmeterol qd or bid versus tiotropium qd and salmeterol bid following 4-week treatment periods in patients with chronic obstructive pulmonary disease (COPD).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Salmeterol Xinafoate; Tiotropium Bromide

Criteria

Inclusion Criteria:

COPD patients of >= 40 years old with moderate to severe COPD who are current or ex-smokers with a smoking history of at least 10 pack-years

Exclusion Criteria:

1. Recent history of myocardial infarction, life-threatening cardiac arrhythmia or hospitalisation for cardiac failure

2. History of asthma

3. Malignancy requiring treatment within past 5 years

4. Life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis

5. Known active tuberculosis

6. Pregnant or nusing women

7. Known hypersensitivity to components of the study medication